Orchid Dermatology Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Orchid Dermatology LLC on 7/23/25. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to safely store two of two Hazardous Waste containers to ensure protection from chemical hazards. Findings included: 1. During a tour of the laboratory on 7/23/25 at 10:30 a.m., two plastic containers labeled as Hazardous Waste with a Flammable Liquid caution sticker on them were observed on top of the laboratory safety flammable cabinet. 2. The Histology tech confirmed on 7/23/25 at 10:50 a.m., the two Hazardous Waste containers should be stored in the laboratory safety flammable cabinet, but there was not enough room. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on July 28, 2023. Orchid Dermatology LLC clinical laboratory was not in compliance with 42 CFR 493, Requirements for Laboratories. The following standard level deficiency was cited: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of peer review records and interview, the laboratory failed to have documentation to verify accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain at least twice annually for one (2022) of two years reviewed (2021-2023). Findings included: Review of the Mohs Quality Control Evaluation forms showed peer review was done on 04/13/2021, 11/02/2021, 09/13/2022, and 01 /12/2023. On 07/28/2023 at 11:40 AM, the Mohs Technician confirmed she could not locate documentation of the second peer review done in 2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5781